BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 371498 · Received January 14, 2002

    Report

    Report Number
    MW1023810
    Event Type
    Malfunction
    Date Received
    January 14, 2002
    Date of Event
    December 31, 2001
    Report Date
    January 7, 2002
    Manufacturer
    ABBOTT INDUSTRIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXTENSION TUBING "SPLIT" UPON PT'S RETURN FROM C.T. SCAN. INCIDENT OCCURRED DURING INJECTION OF CONTRAST VIA PRESSURE INFUSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LITE SHIELD-LATEX FREE TWIN SITE EXT. SET. FPA ABBOTT INDUSTRIES NOT AVAILABLE *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA